Metagenomic Analysis of Gut Microbiome in Korean Patients... | NCT01010815

Studies
Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

NCT01010815

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Nov 10, 2009Estimated

Enrollment

15Estimated

Phase

Not provided

Conditions

Ulcerative Colitis

Interventions

Colonoscopy biopsy
stool collection
colonoscopy biopsy
stool collection

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Nov 2010Estimated

Completion Date

Nov 2011Estimated

First Submitted Date

Nov 8, 2009

First Submission Date that Met QC Criteria

Nov 9, 2009

First Posted Date

Nov 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2009

Last Update Posted Date

Nov 10, 2009Estimated

Name	Class
Ministry of Food and Drug Safety, Korea	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The researchers will investigate gut microbiome in Korean patients with ulcerative colitis and normal control subjects using metagenomic analysis to elucidate the significant difference between two groups This study will help to understand the association between gut microbiome and inflammatory bowel disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UC group		clinically and microscopically confirmed UC patients between the age of 19 and 75 years	Procedure: colonoscopy biopsy Other: stool collection
Control group		normal healthy controls	Procedure: Colonoscopy biopsy Other: stool collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colonoscopy biopsy	Procedure	Colonoscopy biopsy will be performed in rectum, ascending and descending colon at study entry	Control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
characterize the difference in gut microbiomes through metagenomic analysis between UC patients and normal control subjects		1 year

Secondary Outcomes

Measure	Description	Time Frame
characterize the difference in gut microbiomes through metagenomic analysis between stool specimens and biopsy specimens in participants with UC and normal subjects		1 year
characterize the difference in gut microbiomes among colonoscopy biopsy locations (rectum, ascending and descending colon)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between the age of 19 and 75 years
willing to consent/undergo necessary procedures
clinically active or inactive Ulcerative colitis

Exclusion Criteria:

Inability to provide informed consent or
Clinically severe or fulminant ulcerative colitis
Previous abdominal surgery
Pregnancy
Clinically or laboratory-confirmed gastroenteritis for at least 3 months before sampling
the use of antibiotics in the past a month before sampling
the use of probiotics in the past a month before sampling
Severe cardiovascular or pulmonary disease
Severe convulsive disorder and current use of anti-convulsive medication
Malignancy
Transplantation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

gastroenterology clinic at SNUH(Seoul National University Hospital)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joo Sung Kim, M.D., PhD	Contact	+82-2-740-8112		jooskim@snu.ac.kr
Seong-Joon Koh, M.D.	Contact	+82-2-740-8112		jel1206@medimail.co.kr

Overall Officials

Name	Affiliation	Role
Joo Sung Kim, M.D., PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

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Browse Branches

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